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The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.
A court battle between Regeneron and Amgen is testing the legal limits of how far drugmakers can go in using patents to ...
FDA rejection of MDMA-assisted therapy rattles advocates but doesn’t spell end of psychedelics in medicine, experts say By Deidre McPhillips and Carma Hassan , CNN 8 minute read ...